Cocaine AbuseNCT01401270
Prize Contingency Management for Cocaine-Dependent Methadone Patients
A study testing prize contingency management in people with Cocaine Abuse, run by UConn Health at 1 site in United States.
Trial summary
The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Abuse
- What is being tested?
- prize contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- current DSM-IV diagnosis of cocaine dependence
- enrolled at the clinic for >3 months
- on a stable dose of methadone (no changes) for >1 month and not requesting a dose alteration
- submitted >1 clinic cocaine positive sample in the last 6 months
- English speaking
- pass a quiz related to understanding the informed consent form
Who cannot join
- serious, uncontrolled psychiatric illness
- significant cognitive impairment
- in recovery from pathological gambling
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.
- Conditions
- Cocaine Abuse
- Being tested
- prize contingency management
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prize contingency managementBehavioural
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | No intervention | Standard Care |
| Treatment Group B | Experimental | 100% probability of winning a prize with each draw and has 3 prize categories Receives: Behavioral: prize contingency management |
| Treatment Group C | Experimental | 31% probability of winning and has 3 prize categories Receives: Behavioral: prize contingency management |
| Treatment Group D | Experimental | 100% probability of winning and has 7 prize categories Receives: Behavioral: prize contingency management |
| Treatment Group E | Experimental | 31% probability of winning and has 7 prize categories Receives: Behavioral: prize contingency management |
| Treatment Group F | Experimental | usual prize contingency management with a 50% probability of winning from 3 prize categories Receives: Behavioral: prize contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
longest continuous period of cocaine abstinence
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sheila Alessi, UConn Health
- Investigators
- Sheila M Alessi, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401270
- Sponsor's protocol ID
- 10-256-2
- Other IDs
- R01DA013444
- Status last verified
- Mar 2019
- First submitted
- 22 Jul 2011
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prize Contingency Management for Cocaine-Dependent Methadone Patients
- ClinicalTrials.gov ID
- NCT01401270
- Acronym / sponsor ID
- 10-256-2
- Conditions
- Cocaine Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2011 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | No intervention | –Standard Care |
| Treatment Group B | Experimental | Behavioral: prize contingency management100% probability of winning a prize with each draw and has 3 prize categories |
| Treatment Group C | Experimental | Behavioral: prize contingency management31% probability of winning and has 3 prize categories |
| Treatment Group D | Experimental | Behavioral: prize contingency management100% probability of winning and has 7 prize categories |
| Treatment Group E | Experimental | Behavioral: prize contingency management31% probability of winning and has 7 prize categories |
| Treatment Group F | Experimental | Behavioral: prize contingency managementusual prize contingency management with a 50% probability of winning from 3 prize categories |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age > 18 years
- current DSM-IV diagnosis of cocaine dependence
- enrolled at the clinic for >3 months
- on a stable dose of methadone (no changes) for >1 month and not requesting a dose alteration
- submitted >1 clinic cocaine positive sample in the last 6 months
Key exclusion criteria (3 listed)
- serious, uncontrolled psychiatric illness
- significant cognitive impairment
- in recovery from pathological gambling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prize contingency managementParticipants earn the chance to win prizes for the targeted behavior, cocaine abstinence. | Behavioural | Treatment Group B, Treatment Group C, Treatment Group D, Treatment Group E, Treatment Group F |
Primary outcome
longest continuous period of cocaine abstinence
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila M Alessi, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prize contingency management in people with Cocaine Abuse, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
longest continuous period of cocaine abstinence (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.